Ticlopidine Versus Aspirin After Myocardial Infarction (STAMI) Trial - STAMI

Description:

The goal of this study was to assess the safety and efficacy of ticlopidine compared to aspirin among patients who survived an acute myocardial infarction (AMI) treated with thrombolytic therapy.

Hypothesis:

Ticlopidine would be at least as effective as aspirin therapy in secondary prevention among survivors of AMI treated with thrombolysis.

Study Design

Study Design:

Patients Enrolled: 1,470
Mean Follow Up: Six months
Mean Patient Age: Mean age 59 years
Female: 16

Patient Populations:

Patients were eligible to participate in this study if they were >18 years of age and were discharged from the hospital after an AMI that was treated with thrombolytic therapy, and the onset of the AMI was within 30 days of randomization.

Exclusions:

Exclusion criteria included contraindications to the study drugs, the need for oral anticoagulation therapy, scheduled bypass or other major surgery, severe comorbid conditions, low likelihood of follow-up, or participation in other concurrent trials.

Primary Endpoints:

The primary endpoint of this study was the first occurrence of fatal and nonfatal AMI, fatal and nonfatal stroke, angina with objective evidence of ischemia, vascular death, or death from any other cause.

Secondary Endpoints:

Drug-related adverse events

Drug/Procedures Used:

Eligible patients were randomized to receive either aspirin 160 mg/day or ticlopidine 500 mg/day.

Principal Findings:

There was no significant difference in the incidence of the primary endpoint of the first occurrence of fatal and nonfatal AMI, fatal and nonfatal stroke, angina with objective evidence of ischemia, or vascular death or death from any other cause between the aspirin group and the ticlopidine group (8.0% vs. 8.0%, p=0.966). Likewise, there was not a significant difference between the aspirin and ticlopidine groups in terms of adverse events related to the study medication (9.8% vs. 12.3%, p=0.129).

Interpretation:

Among survivors of AMI treated with thrombolytic therapy, ticlopidine was not associated with a reduction in the primary endpoint of the first occurrence of fatal and nonfatal AMI, fatal and nonfatal stroke, angina with objective evidence of ischemia, vascular death, or death from any other cause. Additionally, there was no significant difference between the two groups in terms of adverse events. These findings suggest that ticlopidine did not differ from aspirin in the prevention of adverse clinical events in patients after AMI treated with thrombolytics.

References:

Scrutinio D, Cimminiello C, Marubini E, Pitzalis MV, Di Biase M, Rizzon P. Ticlopidine versus aspirin after myocardial infarction (STAMI) trial. J Am Coll Cardiol 2001;37:1259-65.

Clinical Topics: Atherosclerotic Disease (CAD/PAD)

Keywords: Survivors, Thrombolytic Therapy, Coronary Artery Disease, Myocardial Infarction, Stroke, Platelet Aggregation Inhibitors, Ticlopidine


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